Roche Partner MediLink's B7-H3 ADC Tam-Peli Cuts Death Risk 54% in Relapsed SCLC Phase III
核心洞察
Interim results from the randomized phase III TAISHAN-302 trial show Tam-Peli reduced the risk of death by 54% versus topotecan in relapsed small-cell lung cancer (搜索).
Median overall survival reached 13.3 months with Tam-Peli versus 9.4 months with topotecan, with median progression-free survival of 7.4 versus 2.8 months.
Grade 3 or higher treatment-related adverse events occurred in 46.4% of Tam-Peli patients versus 74.7% of those receiving topotecan.
Roche's collaborator MediLink Therapeutics (搜索) has released interim results from the randomized phase III TAISHAN-302 trial showing that the investigational antibody-drug conjugate Tam-Peli (tambotatug pelitecan (搜索), YL201) significantly improved overall survival versus standard-of-care topotecan in Chinese patients with relapsed small-cell lung cancer (搜索) (SCLC) who progressed after prior platinum-based chemotherapy with or without a PD-L1 inhibitor.
The trial met its primary endpoint of overall survival, with Tam-Peli reducing the risk of death by 54% (median OS 13.3 vs. 9.4 months; stratified HR=0.46; p<0.0001). The data were presented as WCLC 2026 abstract PL02.03.
Secondary Endpoints Favor Tam-Peli
Tam-Peli also demonstrated robust efficacy across secondary endpoints. Median progression-free survival was 7.4 months versus 2.8 months with topotecan, and response rates were 59.1% versus 9.7%.
Consistent OS and PFS improvements were observed across prespecified subgroups, including age, chemotherapy-free interval (<90 vs. ≥90 days), and baseline liver or brain metastatic status. In patients with baseline brain metastases, Tam-Peli extended median intracranial PFS (6.1 months vs. 4.2 months; unstratified HR=0.43; 95% CI: 0.27–0.68) and achieved a higher intracranial response rate (32.4% vs. 2.9%).
Safety Profile
Tam-Peli showed a favourable and manageable safety profile, with lower rates of Grade ≥3 treatment-related adverse events (TRAEs) compared with topotecan (46.4% vs. 74.7%). Serious TRAEs occurred in 25.9% of patients receiving Tam-Peli versus 36.4% with topotecan.
Treatment-emergent interstitial lung disease (ILD/pneumonitis) across all grades occurred in 4.9% of Tam-Peli patients versus 1.4% with topotecan. Grade 3 ILD/pneumonitis events were low in both groups (0.9% each), with no Grade 4 or 5 events reported.
Trial Design and Dosing
TAISHAN-302 (NCT06612151) is a randomized, open-label phase III study evaluating the efficacy and safety of Tam-Peli (2.0 mg/kg intravenously on day 1 of each 21-day cycle, maximum dose 200 mg) compared with topotecan in patients with SCLC who have progressed after one prior line of platinum-based chemotherapy with or without a PD-L1 inhibitor. The trial enrolled 451 patients across 85 study sites in China.
The primary endpoint is overall survival. Key secondary endpoints include investigator-assessed progression-free survival and objective response rate, alongside disease control rate, duration of response, time to response, safety, pharmacokinetics, and immunogenicity.
Mechanism and Regulatory Designations
Tam-Peli is designed to target B7-H3 (搜索), a protein broadly expressed in solid tumours but minimally in normal tissue, allowing it to target cancer cells with high selectivity. Built on MediLink's TMALIN® (Tumour Microenvironment-Activatable Linker) platform, Tam-Peli links a B7-H3-specific monoclonal antibody to a novel topoisomerase 1 inhibitor payload with a drug-to-antibody ratio (DAR) of 8. By combining a stable, hydrophilic linker with a dual-release mechanism, Tam-Peli is designed to deliver its cytotoxic payload both inside tumour cells and extracellularly in the tumour microenvironment, maximizing therapeutic efficacy while minimizing systemic toxicity.
Beyond SCLC, Tam-Peli holds two U.S. Food and Drug Administration Orphan Drug Designations and three China Center for Drug Evaluation Breakthrough Therapy Designations across additional indications, including nasopharyngeal carcinoma (搜索), esophageal squamous cell carcinoma (搜索), and pancreatic cancer (搜索).
Following the positive phase III TAISHAN-301 trial (NCT06629597) in nasopharyngeal carcinoma (搜索), TAISHAN-302 represents the second positive phase III readout for Tam-Peli, conducted in patients in China.
Licensing and Development Plans
Under a collaboration and exclusive licensing agreement between Roche and MediLink Therapeutics (搜索) entered in January 2026, Roche holds development, manufacturing, and commercialization rights for Tam-Peli worldwide, outside mainland China, Hong Kong, and Macau. Roche is advancing clinical development in its licensed territories across multiple solid tumour types and plans to rapidly initiate global phase III trials.
Unmet Need in SCLC
Lung cancer remains the leading cause of cancer-related deaths worldwide, surpassing the combined mortality rates of breast, prostate, and stomach cancers, and claims the lives of 1.8 million people each year. SCLC accounts for 15% of lung cancer diagnoses and is a highly aggressive form of lung cancer that progresses rapidly regardless of the stage of disease at diagnosis. Despite advances in first-line treatment, SCLC frequently relapses or progresses and outcomes remain poor for many people with recurrent disease, highlighting the continued need for more effective treatment options.
Roche's lung cancer portfolio includes approved medicines such as Alecensa® (alectinib), Tecentriq® (atezolizumab), and Rozlytrek® (entrectinib), with an investigational pipeline spanning small-cell lung cancer (搜索), non-small cell lung cancer (NSCLC) with actionable genomic alterations, and NSCLC without actionable genomic alterations.